Addressing Impurities in Pharmaceutical Products: Impurities, Degradants, Residual Solvents and Elemental Impurities
This 2-hr webinar will provide a comprehensive overview of impurities in pharmaceutical products, that require to be controlled, and the strategies for controlling them.
Why Should You Attend:
This webinar is designed to provide an overview of impurities which must be controlled in pharmaceutical products, detailed review of the guidance documents related to each of the categories of impurities and strategies to address each, including reporting of test results. We will discuss drug-related impurities, including process impurities, normal degradation products and potential genotoxic impurities and general impurities (not structurally related to the drug substance), such as residual solvents and elemental impurities.
A comprehensive 7-hr training is available on the same topic. Please click here to view the areas covered in that training.
At the end of this session, attendees will be able to:
* Identify the various categories of impurities likely to be present in pharmaceutical products.
* Be familiar with the guidance documents related to the various categories, and have an understanding of the requirements included in each.
* Develop a strategy for addressing each of the categories of impurities, if appropriate for the particular dosage form.
* Report the results of testing consistent with expectations of regulatory agencies.